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NCT06124157 · ClinicalTrials.gov registry record · Phase 3
A Study Testing the Combination of Dasatinib or Imatinib to Chemotherapy Treatment With Blinatumomab for Children, Adolescents, and Young Adults With Philadelphia Chromosome Positive (Ph+) or ABL-Class Philadelphia Chromosome-Like (Ph-Like) B-cell Acute Lymphoblastic Leukemia (B-ALL)
A Phase 3 study of B Acute Lymphoblastic Leukemia, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 3
- Development phase
- 222
- Enrollment target
- 20
- Study locations
NCT06124157 is a Phase 3 study of B Acute Lymphoblastic Leukemia that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 222 participants, below the 1,016-participant average among 20 other B Acute Lymphoblastic Leukemia trials with a reported enrollment target (78% lower). The trial reports 20 study locations across 9 states.
The verdict
NCT06124157, a Phase 3 study of B Acute Lymphoblastic Leukemia, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 222 participants
- Enrollment target
- 20
- Study locations
Study Summary
This pilot trial assesses the effect of the combination of blinatumomab with dasatinib or imatinib and standard chemotherapy for treating patients with Philadelphia chromosome positive (Ph+) or ABL-class Philadelphia chromosome-like (Ph-like) B-Cell acute lymphoblastic leukemia (B-ALL). Blinatumomab is a bispecific antibody that binds to two different proteins-one on the surface of cancer cells and one on the surface of cells in the immune system. An antibody is a protein made by the immune system to help fight infections and other harmful processes/cells/molecules. Blinatumomab may bind to the cancer cell and a T cell (which plays a key role in the immune system's fighting response) at the same time. Blinatumomab may strengthen the immune system's ability to fight cancer cells by activating the body's own immune cells to destroy the tumor. Dasatinib and imatinib are in a class of medications called tyrosine kinase inhibitors. They work by blocking the action of an abnormal protein that signals cancer cells to multiply, which may help keep cancer cells from growing. Giving blinatumomab and dasatinib or imatinib in combination with standard chemotherapy may work better in treating patients with Ph+ or Ph-like ABL-class B-ALL than dasatinib or imatinib with chemotherapy.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- PROCEDURE Biospecimen Collection
- PROCEDURE Bone Marrow Biopsy
- BIOLOGICAL Blinatumomab
- DRUG Calaspargase Pegol
Study Locations (20)
California
- Loma Linda University Medical Center - Loma Linda
- Miller Children's and Women's Hospital Long Beach - Long Beach
- Children's Hospital Los Angeles - Los Angeles
- UCSF Benioff Children's Hospital Oakland - Oakland
- Kaiser Permanente-Oakland - Oakland
- Children's Hospital of Orange County - Orange
- Lucile Packard Children's Hospital Stanford University - Palo Alto
- Rady Children's Hospital - San Diego - San Diego
- UCSF Medical Center-Mission Bay - San Francisco
Connecticut
- Connecticut Children's Medical Center - Hartford
- Yale University - New Haven
District of Columbia
- MedStar Georgetown University Hospital - Washington D.C.
- Children's National Medical Center - Washington D.C.
Florida
- Golisano Children's Hospital of Southwest Florida - Fort Myers
- UF Health Cancer Institute - Gainesville - Gainesville
Alabama
- Children's Hospital of Alabama - Birmingham
Arizona
- Phoenix Childrens Hospital - Phoenix
Arkansas
- Arkansas Children's Hospital - Little Rock
Colorado
- Children's Hospital Colorado - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 222 participants |
| Start Date | 2025-05-30 |
| Est. Completion | 2030-12-01 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06124157
The ClinicalTrials.gov registry entry for NCT06124157 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 222 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,016-participant average among 20 other B Acute Lymphoblastic Leukemia trials with a reported enrollment target (78% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with B Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT06124157 reports 20 study locations spanning 9 distinct geographic areas - top geographies include California, Connecticut, District of Columbia.
Frequently Asked Questions
What is clinical trial NCT06124157 about?
NCT06124157 is a clinical study titled "A Study Testing the Combination of Dasatinib or Imatinib to Chemotherapy Treatment With Blinatumomab for Children, Adolescents, and Young Adults With Philadelphia Chromosome Positive (Ph+) or ABL-Class Philadelphia Chromosome-Like (Ph-Like) B-cell Acute Lymphoblastic Leukemia (B-ALL)". This pilot trial assesses the effect of the combination of blinatumomab with dasatinib or imatinib and standard chemotherapy for treating patients with Philadelphia chromosome positive (Ph+) or ABL-class Philadelphia chromosome-like (Ph-like) B-Cell acute lymphoblastic leukemia (B-ALL). Blinatumomab...
What is the current status of trial NCT06124157?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 222 participants. The study started on 2025-05-30. Estimated completion is 2030-12-01.
What conditions does trial NCT06124157 study?
This clinical trial studies the following conditions: B Acute Lymphoblastic Leukemia.
What interventions are being tested in trial NCT06124157?
The interventions under investigation include: Cyclophosphamide (DRUG), Biospecimen Collection (PROCEDURE), Bone Marrow Biopsy (PROCEDURE), Blinatumomab (BIOLOGICAL), Calaspargase Pegol (DRUG).
Who is sponsoring clinical trial NCT06124157?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06124157 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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